Full Text View
Tabular View
No Study Results Posted
Related Studies
Long-Term Data Collection From Participants in Adult AIDS Clinical Trials
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), May 2009
First Received: January 28, 2000   Last Updated: November 24, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001137
  Purpose

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.


Condition
HIV Infections

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 4500
Study Start Date: January 2000
Detailed Description:

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in this study will be HIV infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Criteria

Inclusion Criteria

  • HIV-1 infected
  • Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study. More information on this criterion can be found in the protocol.
  • Willing to provide consent for the release and use of clinical data from the parent study
  • Life expectancy of at least 24 weeks
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

  • Active alcohol or drug abuse that may interfere with the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001137

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Betty McCulloch     205-975-7925     bmcc@uab.edu    
United States, California
Univ of California / San Diego Treatment Ctr Recruiting
San Diego, California, United States, 921036325
Contact: Jill Kunkel     619-543-8080     jkunkel@ucsd.edu    
Univ of California, San Francisco/San Francisco General Hosp Recruiting
San Francisco, California, United States, 94110
Contact: Michele Downing, RN     415-514-0550 ext 354     mdowning@php.ucsf.edu    
Stanford Univ Med Ctr Recruiting
Stanford, California, United States, 943055107
Contact: Debbie Slamowitz     650-723-2804     dslam@leland.stanford.edu    
San Mateo AIDS Program / Stanford Univ Active, not recruiting
Stanford, California, United States, 943055107
Univ of Southern California / LA County USC Med Ctr Recruiting
Los Angeles, California, United States, 900331079
Contact: Luis Mendez     323-343-8283     lmendez@hsc.usc.edu    
Harbor UCLA Med Ctr Recruiting
Torrance, California, United States, 90502
Contact: Sally Kruger     310-222-3848     KRUGER@AFP76.HUMC.EDU    
UCLA CARE Ctr Recruiting
Los Angeles, California, United States, 90095
Contact: Susan McCarthy     310-206-8029     smccarthy@mednet.ucla.edu    
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium Active, not recruiting
San Jose, California, United States, 951282699
Marin County Specialty Clinic Active, not recruiting
San Rafael, California, United States, 94903
Willow Clinic Active, not recruiting
Menlo Park, California, United States, 94025
Kaiser Permanente LAMC Active, not recruiting
Los Angeles, California, United States, 90027
UC Davis Med Ctr Active, not recruiting
Sacramento, California, United States, 95814
United States, Colorado
Univ of Colorado Health Sciences Ctr Recruiting
Denver, Colorado, United States, 80262
Contact: Graham M. Ray     303-372-5535     graham.ray@uchsc.edu    
United States, District of Columbia
Georgetown Univ Med Ctr Recruiting
Washington, District of Columbia, United States, 20007
Contact: Candance Levy     202-687-5378     levycj@georgetown.edu    
United States, Florida
Univ of Miami School of Medicine Recruiting
Miami, Florida, United States, 331361013
Contact: Leslie Thompson     305-243-3841     thomps04@pop.fstrf.org    
United States, Georgia
Emory Univ Recruiting
Atlanta, Georgia, United States, 30308
Contact: Beth Dean     404-616-0654     tbdean@emory.edu    
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr Active, not recruiting
Atlanta, Georgia, United States, 303652225
United States, Hawaii
Univ of Hawaii Active, not recruiting
Honolulu, Hawaii, United States, 96816
Tripler Army Med Ctr Active, not recruiting
Tripler Amc, Hawaii, United States, 96859
United States, Illinois
Northwestern Univ Med School Recruiting
Chicago, Illinois, United States, 60611
Contact: Baiba L. Berzins     312-695-5012     baiba@nwu.edu    
Rush Presbyterian - Saint Luke's Med Ctr Recruiting
Chicago, Illinois, United States, 60612
Contact: Jan Fritsche     312-942-5865     jfrits@rush.edu    
Cook County Hosp Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp Recruiting
Indianapolis, Indiana, United States, 462025250
Contact: Beth Zwickl     317-274-8456     Bwzwickl@iupui.edu    
Methodist Hosp of Indiana / Life Care Clinic Active, not recruiting
Indianapolis, Indiana, United States, 46202
Division of Inf Diseases/ Indiana Univ Hosp Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Univ of Iowa Hosp and Clinic Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
Tulane Med Ctr Hosp Active, not recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rebecca Becker     410-955-4370     Becker.Becy@FSTRF.org    
Univ of Maryland, Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201
Contact: Susan LaSalvia     410-706-2785     lasalvia@umbi.umd.edu    
United States, Massachusetts
Harvard (Massachusetts Gen Hosp) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Teri Flynn     617-726-3819     tflynn@partners.org    
Beth Israel Deaconess - West Campus Recruiting
Boston, Massachusetts, United States, 02215
Contact: Helen Fitch     617-632-0785     hfitch@caregroup.harvard.edu    
Boston Med Ctr Recruiting
Boston, Massachusetts, United States, 02118
Contact: Caress Grodman     617-414-3182     carrie.grodman@bmc.org    
Brigham and Women's Hosp Recruiting
Boston, Massachusetts, United States, 02115
Contact: Teri Flynn     617-732-6410        
United States, Michigan
Wayne State Univ. CRS Recruiting
Detroit, Michigan, United States, 48201
Contact: Martha Farrough     313-745-4431     mfarrough@med.wayne.edu    
Principal Investigator: Rodger D. MacArthur, MD            
United States, Minnesota
Univ of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Hennepin County Medical Clinic Active, not recruiting
Minneapolis, Minnesota, United States, 55415
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr Active, not recruiting
St Louis, Missouri, United States, 63112
United States, Nebraska
Univ of Nebraska Med Ctr Recruiting
Omaha, Nebraska, United States, 681985130
Contact: Frances Van Meter     402-559-8163     fvanmete@unmc.edu    
United States, New Jersey
New Jersey Medical School- Adult Clinical Research Ctr. CRS Recruiting
Newark, New Jersey, United States, 07103
Contact: Nancy Reilly     973-972-1268     reillyna@umdnj.edu    
Principal Investigator: Sally Hodder, MD            
Cooper Univ. Hosp. CRS Recruiting
Camden, New Jersey, United States, 08103
Contact: Carol Graeber     856-963-6891     Graeber-carol@cooperhealth.edu    
Principal Investigator: John Baxter, MD            
United States, New York
Univ of Rochester Medical Center Active, not recruiting
Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr Recruiting
New York, New York, United States, 10016
Contact: Maura Laverty     212-263-6565     maura.laverty@med.nyu.edu    
Mount Sinai Med Ctr Recruiting
New York, New York, United States, 10029
Contact: Eileen Chusid     212-241-0433     CHUSID.EILEEN@FSTRF.ORG    
Cornell Univ Med Ctr Active, not recruiting
New York, New York, United States, 10021
SUNY / Erie County Med Ctr at Buffalo Active, not recruiting
Buffalo, New York, United States, 14215
Beth Israel Med Ctr Recruiting
New York, New York, United States, 10003
Contact: Ann Marshak     212-420-4432     marshak.ann@fstrf.org    
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ Recruiting
New York, New York, United States, 10021
Contact: Arlene Hurley     212-327-7281     HURLEYA@ROCKVAX.ROCKEFELLER.EDU    
Columbia Presbyterian Med Ctr Recruiting
New York, New York, United States, 10032
Contact: Mykyelle Crawford     212-305-2665     mc675@columbia.edu    
Chelsea Ctr Recruiting
New York, New York, United States, 10021
Contact: Brenda Greenhill     212-746-4177        
Community Health Network Inc Recruiting
Rochester, New York, United States, 14642
Contact: Carol Greisberger     716-275-5871     carol_greisberger@urmc.rochester.edu    
Bronx-Lebanon Hosp. Ctr. CRS Recruiting
Bronx, New York, United States, 10457
Contact: Noemi Olivo     718-901-6346     nolivo@bronxleb.org    
United States, North Carolina
Carolinas Med Ctr Active, not recruiting
Charlotte, North Carolina, United States, 28203
Univ of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 275997215
Contact: Barbara Longmire     919-966-7883     LONGBAR@MED.UNC.EDU    
Moses H Cone Memorial Hosp Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Pam Mentley     910-574-7888     pam.mentley@mosescone.com    
Duke Univ Med Ctr Recruiting
Durham, North Carolina, United States, 27710
Contact: Paulette MacDougall     919-668-0161     mcdou006@mc.duke.edu    
Wake County Department of Health Active, not recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Univ of Cincinnati Recruiting
Cincinnati, Ohio, United States, 452670405
Contact: Tammy Powell     513-584-8373     powelltm@email.uc.edu    
Ohio State Univ Hosp Clinic Recruiting
Columbus, Ohio, United States, 432101228
Contact: Judith Neidig     614-293-8112     NEIDIG.1@OSU.EDU    
MetroHealth Med Ctr Recruiting
Cleveland, Ohio, United States, 441091998
Contact: Nancy Frantz     216-459-5136        
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44106-5083
United States, Pennsylvania
Univ of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christine Tripoli     412-647-0771     tripolica@msx.upmc.edu    
Univ of Pennsylvania at Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christopher Helker     215-349-8092     chelker2@mail.med.upenn.edu    
Presbyterian Medical Center - Univ. of PA Recruiting
Norristown, Pennsylvania, United States, 19401
Contact: Maureen T O'Connell, RN, BSN     215-349-8092     maureen.oconnell@uphs.upenn.edu    
United States, South Carolina
Julio Arroyo Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Michael Klebert     314-454-0058     MKLEBERT@IMGATE.WUSTL.EDU    
United States, Tennessee
Vanderbilt Univ Med Ctr Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Univ of Texas, Southwestern Med Ctr of Dallas Active, not recruiting
Dallas, Texas, United States, 75390
Houston AIDS Research Team CRS Recruiting
Houston, Texas, United States, 77030
Contact: Robert C. Arduino, MD     713-500-6713     roberto.c.arduino@uth.tmc.edu    
Principal Investigator: Ben J. Barnett            
Principal Investigator: Roberto C. Arduino, MD            
United States, Washington
Univ of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Jeanne Conley     206-731-8877     njc@u.washington.edu    
Puerto Rico
Univ of Puerto Rico Recruiting
San Juan, Puerto Rico, 009365067
Contact: Virginia Ramirez     787-767-9192     ramirez.virginia@fstrf.org    
Sponsors and Collaborators
Investigators
Study Chair: Constance A. Benson, MD Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair: Ann C. Collier, MD University of Washington, Harborview Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: DAIDS ( Rona Siskind )
Study ID Numbers: ACTG A5001, AACTG A5001
Study First Received: January 28, 2000
Last Updated: November 24, 2009
ClinicalTrials.gov Identifier: NCT00001137     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Treatment Naive
Virus Replication
AIDS-Related Opportunistic Infections
HIV-1
Risk Factors
Incidence
RNA, Viral
Anti-HIV Agents
Viral Load
Lipodystrophy
Nervous System
Cardiovascular System

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009